1. Field of the Invention
The present invention relates to a needle array adapted to deliver sutures for the anastomosis of two separated tissues through the intermediary of suturing and sewing, and more particularly pertains to a novel needle array delivering sutures for the side-to-side anastomosis of two separated vessels, such as an artery or body lumen and a vessel graft or the like. Moreover, the invention is directed to a novel method of utilizing a needle array which will provide sutures for sewing separated tissues together, and especially facilitates the side-to-side anastomosis of body lumens or vessels.
The concept of anastomosis or the joining through the sewing or suturing of body vessels is widely known in the medical art. In particular, in order to suture or anastomotize two vessels, a single needle or hook element having a suture attached thereto is passed through the intimal tissue of the body vessels or grafts at specified locations, and the suture is then tightened and knotted so as to provide a closed connection between the adjoining tissues of the two body vessels. This procedure is then continually repeated by means of multiple needle passes until the required vessel/graft connection is completed.
The difficulties which are encountered in implementing the foregoing reside in that the use of individual needles, of necessity requires an extensive period of time in the implementation of the suturing and sewing process, this, in turn, increasing the risk of complication to a patient and with the attendant potential of morbidity and difficulty in healing of the sutured location.
In essence, as described by the present state-of-the medical technology which is concerned with the use of individual needles and thereto attached sutures in order to implement and complete anastomosis between body vessels and/or grafts, either multiple passes of the needle and suture are required, or it is necessary to effectuate a movement of the object which is being subjected to anastomosis, such as the grafts and/or body vessels, which to a considerable extent increase the difficulties in healing, causing pain and discomfort to the patient; while possibly enhance of the risk of morbidity or even mortality.
2. Discussion of the Prior Art
For instance, among various publications which relate to the implementation of anastomosis, is the use of a microsurgery tool as described in Narayanan et al. U.S. Pat. No. 4,803,984. However, this only provides for a single suture with a needle attached thereto puncturing through the tissue of adjacent vessel wherein the suturing is implemented in an end-to-end anastomosis. Basically, a large number of needle passes is required in order to extend about the circumferentially aligned ends of the adjoining vessels which, in effect is an extremely lengthy and difficult procedure subject to potential pain and physical harm to a patient.
Other aspects in implementing anastomosis reside in the use of clamps, such as disclosed in Schenck U.S. Pat. No. 4,593,693 in order to interengage the tissue of adjoining vessels and grafts.
Similarly, Bolduc et al. U.S Pat. No. 5,976,159 discloses anastomosis through the implementation of surgical clips which are adapted to engage adjacent vessels or body lumens in various mutual orientations, such as would facilitate side-to-side anastomosis procedures.
Other publications relate to the implementation of anastomosis by the use of various means, such as through clips or various types of clamps intended to interconnect body vessels. For example, such publications are Whitehill et al. U.S. Pat. No. 3,019,789; Gifford III et al. U.S. Pat. Nos. 5,695,504 and 5,904,697; and Spence et al. U.S. Pat. No. 5,868,763.
In order to overcome the limitations and shortcomings of the prior art in the suturing of tissues of separated body vessels and/or grafts in preferably side-to-side anastomosis, pursuant to the invention there is provided a needle array which in a concurrent mode is adapted to cause the needle array with an attached suture pass through the tissue of two superimposed vessels. The array of needles is provided with a single suture which is formed in a loop configuration extending over the tip of each needle such that the leading ends of the loops project beyond the punctured tissues. The needles are notched to enable a further suture to be passed through collectively each of the loops and the needles are then withdrawn leaving the sutures interengaged. Thereafter the sutures are tightened to draw the tissues of the vessels together and knotted so as to complete the entire anastomosis in essentially a single operative step.
Accordingly, it is an object of the present invention to provide a novel needle and suture array whereby a plurality of needles collectively bearing a single suture in a plurality of loops are adapted to concurrently pierce through the tissues of separated vessels and/or grafts and whereby a further suture is passed through the collective loops and the needle array retracted therefrom so as to enable the sutures to tighten the tissues together and then are knotted to anastomotize the vessels.
Another object of the present invention resides in a novel method of suturing two separated body vessels and/or grafts by passing concurrently a plurality of needles and a looped suture supported thereon in an array through the tissues of the vessels, forming a succession of suture loops through which a further suture is then passed, whereupon the needles are withdrawn, and the sutures are tightened and knotted to provide the required anastomosis of the body vessels or lumens in essentially a single operation.